Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT03237767
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥ 12 years of age
* CF diagnosis based on clinical features, supported by an abnormal sweat test (sweat chloride \> 60 mmol·L-1 \> 100 mg sweat) and, where possible, diagnostic genotyping
* No contraindications to performing exhaustive exercise
* Can understand and cooperate with the study protocol
* No increase in symptoms or weight loss in the preceding 2 weeks
Exclusion Criteria:
* Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy).
* Unstable co-morbid asthma (daily pulmonary function variability of \> 20%)
* Is pregnant during the initial screening process
* Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
* Not of a suitable age for testing
Exclusion during testing:
* Onset of acute infection
* Becomes and/or is tested to be pregnant following enrolment to the study
* Experiences significant hypoxaemia during visit 2 of the CFit\_BL protocol (IRAS ID: 225310) which requires supplemental O₂. Under these circumstances, participants will be invited to continue their participation under the CFit\_BL trial (IRAS ID: 225310)
* Unable to understand or cooperate with study protocol
* The individual does not wish to participate further
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03237767
Study Brief:
Protocol Section:
NCT03237767